![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
EU WC
Listed Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
Aerami will be responsible for the overall development and commercialisation of inhaled imatinib, with Vectura providing development services expertise and a license to its FOX® mesh nebuliser technology.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aerami
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 08, 2020
Details:
AV-101 (imatinib) is a novel dry powder inhaled formulation which inhibits the BCR-ABL tyrosine kinase. It is being evaluated for the treatment of pulmonary arterial hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2024
Details:
AV-101 (imatinib) is a novel dry powder inhaled formulation which is being evaluated for the treatment of pulmonary arterial hypertension. It is a protein-tyrosine kinase inhibitor that inhibits the bcr-abl tyrosine kinase.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2023
Details:
AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2023
Details:
AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
Details:
AER-901 (imatinib mesylate) is a tyrosine kinase inhibitor of PDGFR α and β kinases, Abl, DDR, and c-KIT may therefore prove efficacious in the treatment of pulmonary arterial hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
The Company intends to use the net proceeds to progress the clinical development of TNX-201 (imatinib) for the treatment of PAH and levosimendan for the treatment of PH-HFpEF, toward regulatory approval for the treatment of these and potentially other indications.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Roth Capital Partners
Deal Size: $15.6 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 03, 2023
Details:
AER-901 is a drug-device combination that is designed to deliver potentially reverse-remodeling therapy with imatinib mesylate deeply and efficiently throughout the diseased tissue of the lung via the FOX® nebulizer.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AER-901
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2022
Details:
AV-101 is an investigational, proprietary dry powder inhaled formulation of the anti-proliferative drug imatinib. Developed specifically for PAH, AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
TNX-201 (imatinib), a novel, oral, modified release formulation, a kinase inhibitor that has received FDA’s orphan designation for the treatment of pulmonary arterial hypertension (PAH).
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2022
Details:
The IMPRES trial, demonstrated that oral TNX-201 (imatinib) may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, in those patients who were maintained on full imatinib dose for majority of trial.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Tenax expects to use the proceeds from this offering to further its clinical trials of levosimendan and imatinib (TNX-201), for research and development and for general corporate purposes, including working capital.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TNX-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $8.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 18, 2022
Details:
The Phase 1 results show that AV-101 (Imatinib) delivered by dry powder inhalation was generally well tolerated and significantly reduced systemic exposure compared with oral imatinib in healthy adult participants.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AV-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
The Company will be presenting it's two lead drug candidates, imatinib and levosimendan, both of which are currently in late-stage development for the treatment of pulmonary hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TNX-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
AV-101 (imatinib) is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects and, dosed specifically for pulmonary arterial hypertension.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
AV-101 (dry powder inhaled imatinib) initiated Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) Phase 2b/Phase 3 trial to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in adult patients with Pulmonary Arterial Hypertension (PAH).
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2021
Details:
Proceeds from the transaction will be applied toward advancing AER-901, Aerami’s proprietary inhaled, nebulized formulation of imatinib into a planned Phase 2/3 clinical trial in 2022.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AER-901
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: FoxWayne Enterprises
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger December 07, 2021
Details:
Aerami will undertake its own PAH clinical development program in the US and other territories for AER-901, drug device combination product pursuant to a worldwide license from Vectura Group plc to develop and commercialize imatinib for the treatment of PAH.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AER-901
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hangzhou Chance Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 09, 2021
Details:
The acquisition expands Tenax’s pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate. Imatinib is a tyrosine kinase inhibitor that transformed the treatment of cancer by blocking the underlying pathways resulting in long lasting remissions.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tenax Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 19, 2021
Details:
Funding will advance trials of AV-101, an inhaled, dry powder aerosol version of imatinib to treat pulmonary arterial hypertension (PAH). An oral version of imatinib showed significant efficacy in a phase 3 trial as a disease-modifying therapy for PAH.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AV-101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RA Capital Incubator
Deal Size: $72.6 million Upfront Cash: Undisclosed
Deal Type: Series A Financing August 06, 2020
Details:
Under the award, Exvastat will collaborate with Vrije Universitat, Amsterdam Medical Center, KABS (Canada) and Simbec-Orion to produce a reformulated version of imatinib and test it in critically ill COVID-19 patients.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovative Medicines Initiative
Deal Size: $3.9 million Upfront Cash: Undisclosed
Deal Type: Funding May 15, 2020
Details:
Post-dose vision in all YD-312 dose groups compared with pre-dose was statistically significant, visual acuity was maintained, or the treatment efficiency improved significantly compared to the placebo group, the official noted.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
AI VIVO is seeking pharma and biotech collaboration partners to progress therapeutic candidates that have been identified by the Company as “top-ranked” for COVID-19.
Lead Product(s): Imatinib Mesylate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 07, 2020